1. Field of Invention
This invention relates to a nasal dilator, particularly to such a device which is designed to reduce airway resistance and therefore aid air flow through both the nasal and posterior pharyngeal regions of the upper airway.
2. Discussion of the Prior Art
Upper airway resistance to airflow is an affliction which affects millions of individuals and has very serious medical consequences with significant morbidity and mortality. The health effects are brought about by the disruption of normal sleep of those afflicted with snoring and sleep apnea (complete stoppage of breathing for a period of time). The effects of snoring and sleep apnea may also compromise the well being of those sleeping in proximity to the afflicted person by disrupting their ability to achieve healthy, restful sleep.
Sleep is impacted by both the increased effort needed to overcome increased resistance to airflow and by the fragmentation of sleep patterns brought about by awakenings that occur in both hyponia (reduced air flow) and apneic events (periods of stoppage of air flow). These conditions limit one's ability to go into the deeper stages of sleep that are necessary to refresh and restore and are damaging to many body systems.
The primary treatment for snoring and apnea is the use of a device, referred to as a CPAP (Continuous Positive Air Pressure) device. This device delivers pressurized air from a pumping component through a hose to a mask which is secured over the nose of the individual. This is successful at correcting the problem but is not well tolerated by a significant group of individuals due to the discomfort, lifestyle issues, and difficulty in the portability in traveling with the CPAP. Because of these factors a significant number of patients are forced to abandon the use of this therapy.
Surgical techniques have been available for many years; these attempt to permanently correct snoring problems encountered by individuals. However such surgical procedures are complicated and invasive and sometimes permanently change the appearance of the individual. In addition, numerous medical drawbacks, including cost, irreversibility, surgical risk, and long painful recovery periods, are inherent in surgical procedures.
Numerous devices are known which attempt to alleviate or eliminate snoring problem without invasive surgery. Some devices have focused on improving airflow through the nose. These devices are used both in awake periods, during increased demand such as athletic usage, and during sleep to improve airflow as an anti-snoring device.
There are two mechanisms: one attaches to the external skin of the nose on the right and left sides of by means of adhesives which act by pulling the skin outward to strengthen and expand the nasal passages. (Ruch, U.S. Pat. No. 6,375,667, Apr. 23, 2002) This device is disposable and can irritate the skin. Other such devices are designed to fit inside the nasal passageway and push the inner walls of the nose out, expanding the air passage. (Corsaro, U.S. Pat. No. 5,727,543, Mar. 17, 1998). This device can irritate the sensitive inner lining of the mucosa of the nasal passageway and is awkward.
There are also numerous devices known which attempt to alleviate or eliminate snoring problems without invasive surgery by repositioning the lower jaw (mandible) in an anterior (forward) direction. This pulls the base of the tongue forward and thereby increases the air passage in the posterior pharyngeal region (breathing passage behind the base of the tongue).
Devices which bring the mandible forward into a functional repositioning posture, and which hold the posterior airway open, fall into two general categories. The first is non-adjustable: the device fits in the mouth at a prescribed position. The disadvantage of this is that there are changes over time that occur and therefore may require changing the position of the lower jaw in relationship to the upper jaw over a period of time.
Devices which are adjustable have significant components inside the mouth behind the teeth. They take up space inside the mouth, restricting the space for the tongue and preventing it from coming forward. Some devices also have projections which extend from the mouth out between the lips. These affect the user's ability to close their lips, making the appliance less comfortable and inhibiting the ability of the user to turn to different positions during sleep.
Thus all known devices and techniques for improving airflow have one or more drawbacks or disadvantages.